Savient Receives FDA Final Approval for Puricase (PEG-uricase) Phase 3 Special Protocol Assessment (SPA); Patient Dosing to Begin in May

Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) a specialtypharmaceutical company focused on developing, manufacturing andmarketing novel therapeutic products for unmet medical needs,announced today that the Company has received written notificationfrom the U.S. Food and Drug Administration (FDA) that the Agency hasapproved a Special Protocol Assessment (SPA) for the two replicatePhase 3 clinical trials for its lead drug, Puricase(R) (PEG-uricase).As previously announced the Company held its Phase 3 clinicalinvestigators meeting at the end of March and plans to begin patientdosing in May.

Christopher G. Clement, President and Chief Executive Officer ofSavient commented, "This final step in the formal process to receiveapproval from the FDA on our Special Protocol Assessment for the Phase3 trials for Puricase is a major milestone for the Company. It allowsus to remain on track for commercialization of Puricase with a BLAfiling with the FDA targeted for late 2007. As previously stated, theCompany's full efforts and resources are being devoted towards theclinical development program and commercialization of this product fortreatment-failure gout."

Zeb Horowitz, MD, Savient Chief Medical Officer said, "Thefinalization of the SPA is very important to us, because it is aformal, written agreement with the FDA Review Division on the design,execution, and analysis of the Phase 3 pivotal studies in the Orphangout (treatment-failure) population. Because our approach to thetreatment of gout is novel, upfront agreement with FDA on theregistration studies became a crucial component of our developmentstrategy. The SPA process was a bit slower than we would have liked,but we have been able to use the time productively to progressInstitutional Review Board reviews and approvals, complete trainingand pre-study preparations of clinical site staff and centrallaboratories, and generally to limber up for a successful study startand race to complete patient recruitment."

About Puricase(R) Phase 3 Clinical Study

The Phase 3 program is designed to compare the safety and efficacyof Puricase (PEG-uricase) administered by two-hour intravenousinfusion every two weeks or every four weeks versus placebo infusion,over a six-month period. The program design consists of two replicatesix-month placebo-controlled trials of approximately 100 randomizedpatients each. All patients who complete the placebo-controlled trialswill be invited to participate in a long-term open label extension,which the FDA suggested to continue for two years. Therefore, patientswho are randomized to the placebo arms will be eligible to receivePuricase (PEG-uricase) treatment in an open label extension trialfollowing completion of the six-month controlled registration trial.

Each of the two trials is independently powered for the primaryefficacy (or key registration) endpoint, a responder analysisassessing the proportion of patients who have normalized plasma uricacid at month 3 and month 6. Secondary efficacy endpoints will beassessed in a population pooled from the two trials. These endpointswill include an assessment of the reduction in burden of gout tophiusing digital photography, reduction in the frequency of gout flares,improvement in the count of swollen and tender joints, andimprovements in patient reported outcomes using the Short Form 36(SF-36) and the Health Assessment Questionnaire-Disability Index(HAQ-DI).

Savient licensed exclusive, worldwide rights to the technologiesrelated to Puricase (PEG-uricase) from Duke University ("Duke") ofNorth Carolina and Mountain View Pharmaceuticals, Inc. ("MVP"), aCalifornia corporation. Duke developed the recombinant porcine uricaseenzyme and MVP developed the PEGylation technology. MVP and Duke weregranted U.S. and foreign patents covering the licensed technology.Puricase is a registered trademark of Mountain View Pharmaceuticals,Inc.

ABOUT SAVIENT

Based in East Brunswick, New Jersey, Savient Pharmaceuticals,Inc., is an emerging specialty pharmaceuticals company and is engagedin developing, manufacturing and marketing pharmaceutical productsthat address unmet medical needs in both niche and broader markets.The Company's lead product development candidate, Puricase(R)(PEG-uricase), for the treatment of refractory gout has reportedpositive Phase 1 and 2 clinical data. Savient's experienced managementteam is committed to advancing its pipeline and expanding its productportfolio by in-licensing late stage compounds and exploringco-promotion and co-development opportunities that fit the Company'sexpertise in specialty pharmaceuticals and initial focus inrheumatology. Savient markets its product Oxandrin(R) (oxandrolone,USP) in the United States. The Company's subsidiary, RosemontPharmaceuticals Ltd., develops, manufactures, and markets through itsown sales force oral liquid formulations of prescription products forthe UK pharmaceutical market. Rosemont's product portfolio includesover 100 liquid formulations primarily targeting the geriatricpopulation. Puricase is a registered trademark of Mountain ViewPharmaceuticals, Inc. Further information on the Company can beaccessed by visiting: www.savientpharma.com

FORWARD LOOKING LANGUAGE

This news release contains forward-looking statements within themeaning of Section 21E of the Securities Exchange Act of 1934. Allstatements, other than statements of historical facts, included inthis report regarding the Company's strategy, expected futurefinancial position, results of operations, cash flows, financingplans, discovery and development of products, strategic alliances,competitive position, plans and objectives of management areforward-looking statements. Words such as "anticipate," "believe,""estimate," "expect," "intend," "plan," "will" and other similarexpressions help identify forward-looking statements, although not allforward-looking statements contain these identifying words. Inparticular, the statements regarding the clinical development ofPuricase (PEG-uricase), commencement of the Phase 3 clinical trial forPuricase (PEG-uricase), time for completion of patient recruitment andtiming for the filing of an NDA for Puricase (PEG-uricase) areforward-looking statements. These forward-looking statements involvesubstantial risks and uncertainties and are based on currentexpectations, assumptions, estimates and projections about theCompany's business and the biopharmaceutical and specialtypharmaceutical industries in which the Company operates. Such risksand uncertainties include, but are not limited to, the Company'sability to find a buyer for Rosemont Pharmaceuticals and to negotiateand consummate a sale of Rosemont at an attractive price; delay orfailure in developing Puricase and other product candidates;difficulties of expanding the Company's product portfolio throughin-licensing; introduction of generic competition for Oxandrin;fluctuations in buying patterns of wholesalers; potential futurereturns of Oxandrin or other products; the Company's continuing toincur substantial net losses for the foreseeable future; difficultiesin obtaining financing; potential development of alternativetechnologies or more effective products by competitors; reliance onthird-parties to manufacture, market and distribute many of theCompany's products; economic, political and other risks associatedwith foreign operations; risks of maintaining protection for theCompany's intellectual property; risks of an adverse determination inon-going or future intellectual property litigation; and risksassociated with stringent government regulation of thebiopharmaceutical and specialty pharmaceutical industries. The Companymay not actually achieve the plans, intentions or expectationsdisclosed in its forward-looking statements, and you should not placeundue reliance on the Company's forward-looking statements. Actualresults or events could differ materially from the plans, intentionsand expectations disclosed in the forward-looking statements that theCompany makes. The Company's forward-looking statements do not reflectthe potential impact of any future acquisitions, mergers,dispositions, joint ventures or investments that the Company may make.The Company does not assume any obligation to update anyforward-looking statements.

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